Overview

Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
Female
Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment. PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Tamoxifen
Criteria
Inclusion:

Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in
situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months
either for the treatment of invasive or non-invasive carcinoma of the breast or for breast
cancer recurrence prevention

- Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor
status not specified Concurrent participation in non-treatment studies allowed
provided it will not interfere with participation in this study Menopausal status not
specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life
expectancy ≥ 6 months Absolute Neutrophil Count (ANC) ≥ 1.0 x 10^9/L Platelet count ≥
100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5
times Upper Limit of Normal (ULN) Total bilirubin ≤ 2.5 times ULN Creatinine clearance
≥ 50 mL/min Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- No limitations to number of prior therapies

- No limitations for prior radiotherapy

- More than 14 days since prior and no other concurrent investigational agent

Exclusion:

Not pregnant or nursing No active, serious infection or medical or psychiatric illness
likely to preclude study participation No psychiatric conditions that would preclude study
compliance or informed consent No history of venous thromboembolism, transient ischemic
attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate
or any of its reagents No concurrent coumadin

No concurrent medications known to inhibit CYP2D6, including any of the following:

- Amiodarone

- Haloperidol

- Indinavir

- Ritonavir

- Quinidine

No concurrent selective serotonin reuptake inhibitors, except the following:

- Venlafaxine

- Citalopram